CRED SMPC 2024

Leaflet requirements (3/4)

4. Possible side effects

- Serious side effects that require immediate attention must be listed first, regardless of frequency - Other side effects to be listed according to frequency (most common first) - Clear instructions for action to be taken by patient - Details for patient reporting of side effects

5. How to store X

- Expiry date reference - Storage conditions - In use shelf life (if applicable) - Signs of deterioration (if applicable) - Disposal

9

9

Leaflet requirements (4/4)

6. Further Information

- What X contains - What X looks like and the contents of the pack - MA holder and manufacturer details - Local representatives

10

10

5